MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DESIGN OPTIONS®; EPIDURAL ANESTHESIA KIT

Catalog Number	552153
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: brief inquiry description: broken/snapped fx catheter.Detailed inquiry description: end user reporting a broken fx catheter used on one of their or patients placed for post-op pain management.Patient was moved to a lateral position and that is when the catheter snapped with the springwound coil exposed.Per the doctor, nothing unusual noted about the catheter and there was no excessive force or pulling of catheter to have caused this.They suspect there was a material defect in the catheter material.They were only visually alerted by it.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One used, partial catheter with lidstock packaging was returned for evaluation.Visual evaluation of the photo confirmed the catheter to be sheared approximately 30" from the distal tip of the catheter, with the coil exposed.The reported defect was visually confirmed.Although the defect was confirmed on the returned sample, the exact root cause of the sheared catheter was not able to be determined at this time.According to the blueprint drawing, there have been no change to any material of the catheter.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: DESIGN OPTIONS®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21997909
• Report Number: 2523676-2025-00445
• Device Sequence Number: 21203215
• Product Code: OGE
• UDI-Device Identifier: 04046955214426
• UDI-Public: (01)04046955214426(11)240930(17)251231(10)0061960428
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 552153
• Device Lot Number: 0061960428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown